Cytomegalovirus (CMV), Congenital, Qualitative PCR, Saliva Swab

Clinical Use

Use

This test is intended for the in vitro qualitative detection of cytomegalovirus (CMV) DNA from salvia swabs collected in universal transport (UTM) or viral transport media (VTM) from infants <21 days of age. Results from this assay should be used in conjunction with the results of other clinical findings as an aid in the diagnosis of congenital CMV infection. Positive results from a saliva swab are presumptive and should be confirmed with urine.

Special Instructions

Not provided.

Limitations

The test result should be considered in conjunction with clinical history, epidemiological data, and other laboratory information. Negative results do not rule out congenital CMV infections and should not solely guide treatment decisions. False negatives may occur due to sample mismanagement or if the virus level is below the assay's sensitivity. Prevalence rates of infections affect predictive values. Positive saliva swab screenings should be followed by urine testing to confirm congenital CMV infection.

Test Details

Methodology

PCR-based (PCR)

Biomarkers

Cytomegalovirus (CMV), DNA

Microorganism

Other

Other • Binary (Detected / Not Detected)

LOINC Codes

Order Codes

83065-3 - CMV DNA Sal Ql NAA+probe

Result Codes

83065-3 - CMV DNA Sal Ql NAA+probe

Result Turnaround Time

3 days

Specimen

Saliva

Volume

1 swab

Minimum Volume

1 swab

Container

Universal Transport Media (UTM); Viral Transport Media (VTM), including UVT, MART, M4 and M6

Collection Instructions

A saliva swab should be collected at least one hour after breastfeeding. Insert a sterile polyester swab into the baby's mouth between the gum and cheek and swirl for several seconds. Remove the swab and place into the UTM or VTM container. Carefully break the swab at the score line and submit for testing.

Storage Instructions

Refrigerate. Refrigerated swabs are stable for 7 days, frozen swabs for 14 days (-20°C).

Causes for Rejection

Saliva swabs not submitted in UTM or VTM; saliva swabs submitted in non-approved collection containers; e-swabs or other collection devices intended for bacterial culture; collection containers submitted without a swab; saliva swabs submitted from patients >21 days of age